Product code LSY
- Device name
- Ultrasound, Hyperthermia, Cancer Treatment
- Medical specialty
- Unknown
- Device class
- 3
- Review panel
- RA
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related PMA Records#
| PMA | Device | Applicant | Decision date |
|---|---|---|---|
| P040003S001 | EXABLATE 2000 MRI GUIDED FOCUSED ULTRASOUND SYSTEM | Insightec, Ltd. | 2005-12-30 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 07290015461948 | HEAD FRAME SET FOR TYPE 1.1 SYSTEMS (R20) | INSIGHTEC LTD | 2021-08-10 |
| 07290015461931 | HEAD FRAME SET FOR TYPE 1.0 SYSTEMS (R20) | INSIGHTEC LTD | 2021-08-10 |
| 07290015461924 | INSIGHTEC HEAD FRAME+INTEGRA PINS 1.0 SET | INSIGHTEC LTD | 2021-08-10 |
| 07290015461917 | Low Height Head Frame Set NEURO-V2 (Inegra) | INSIGHTEC LTD | 2021-08-10 |
| 07290015461467 | ExAblate 2100V1 LOWER PELVIC COIL ASSEMBLY ARTIST 1.5T | INSIGHTEC LTD | 2018-11-29 |
| 07290015461450 | ExAblate 2100V1 LOWER PELVIC COIL 1.5T | INSIGHTEC LTD | 2018-11-29 |
| 07290015461504 | ExAblate 2100/2100V1/2100V1-AR UPPER PELVIC COIL | INSIGHTEC LTD | 2018-11-29 |
| 07290015461498 | ExAblate 2100 LOWER PELVIC COIL ASSEMBLY | INSIGHTEC LTD | 2018-11-29 |
| 07290015461481 | ExAblate 2100V1 Pelvic RF Coil for 1.5T Artist MR | INSIGHTEC LTD | 2018-11-29 |
| 07290015461474 | ExAblate 2100V1 Pelvic RF Coil 1.5T | INSIGHTEC LTD | 2018-11-29 |
| 07290015461245 | Neuro Helmet Sealant | INSIGHTEC LTD | 2017-07-31 |
| 07290015461238 | Neuro Patient Accessory Kit | INSIGHTEC LTD | 2017-07-31 |
| 07290015461160 | neuro cleaning kit for USA | INSIGHTEC LTD | 2017-06-30 |
| 07290015461252 | 1L degasseed water pouch | INSIGHTEC LTD | 2017-06-07 |
| 07290015461221 | HEAD RING SCREWS LONG | INSIGHTEC LTD | 2017-06-07 |
| 07290015461214 | Exablate DQA Phantom Gel | INSIGHTEC LTD | 2017-06-07 |
| 07290015461207 | NEURO DQA PHANTOM GEL | INSIGHTEC LTD | 2017-06-07 |
| 07290015461191 | NEURO TREATMENT ACCESSORIES KIT | INSIGHTEC LTD | 2017-06-07 |
| 07290015461184 | Neuro Head coil | INSIGHTEC LTD | 2017-06-07 |
| 07290015461177 | Neuro membrane | INSIGHTEC LTD | 2017-06-07 |
| 07290015461146 | Neuro Kit 1.5T for USA | INSIGHTEC LTD | 2017-06-07 |
| 07290015461122 | Neuro Kit 3T for USA | INSIGHTEC LTD | 2017-06-07 |
| 07290015461115 | Pelvic RF Coil | INSIGHTEC LTD | 2017-06-07 |
| 07290015461108 | Scar Patch | INSIGHTEC LTD | 2017-06-07 |
| 07290015461085 | Gel Pad ASSY | INSIGHTEC LTD | 2017-06-07 |
| 07290015461054 | water bag kit | INSIGHTEC LTD | 2017-06-07 |
| 07290015461047 | Patient accessory kit | INSIGHTEC LTD | 2017-06-07 |
| 07290015461023 | EXABLATE NEURO | INSIGHTEC LTD | 2016-08-03 |
| 07290015461016 | EXABLATE | INSIGHTEC LTD | 2016-08-03 |
| 07290015461009 | EXABLATE | INSIGHTEC LTD | 2016-08-03 |